ISO 13485
Medical Devices Quality Management Systems
WHY TRAIN WITH VELOCITY 360?
Velocity 360 training products are developed within our ISO 9001:2015 quality management system, certified by NQA, an ANAB-accredited certification body. We are also an Exemplar Global Certified Training Provider for select training programs.
Select an individual certification course or a multi-course professional development program based on your role, responsibilities, and medical device quality and FDA compliance goals.
PROFESSIONAL PROGRAM
This On-Demand program includes five e-courses covering ISO 13485:2016 lead auditing, ISO 14971 risk management, FDA QMSR, Good Documentation Practice and ALCOA+, and FMEA.
● 48 Hours ● 4.8 CEUs ● 6 Certificates of Competence ● Spanish
INDIVIDUAL CERTIFICATION COURSE
This On-Demand e-course provides practical instruction in ISO 13485:2016 medical device QMS requirements and ISO 19011:2026 guidance for conducting and leading management system audits.
● 32 Hours ● 3.2 CEUs ● Certificate of Competence ● Spanish
PROFESSIONAL PROGRAM
This On-Demand program includes four e-courses covering ISO 13485:2016 medical device QMS internal auditing, ISO 14971 risk management, Good Documentation Practice and ALCOA+, and FMEA.
● 38 Hours ● 3.8 CEUs ● 4 Certificates of Competence ● Spanish
INDIVIDUAL CERTIFICATION COURSE
This On-Demand e-course provides practical instruction in ISO 13485:2016 medical device QMS requirements and ISO 19011:2026 guidance for conducting internal audits.
● 24 Hours ● 2.4 CEUs ● Certificate of Competence ● Spanish
INDIVIDUAL CERTIFICATION COURSE
This On-Demand e-course provides practical instruction in the concepts and requirements of ISO 13485:2016 for medical device quality management systems.
● 16 Hours ● 1.6 CEUs ● Certificate of Competence ● Spanish